Project CORE: Disseminating Eating Disorders Treatment

Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population

The goals of this project are to 1) develop training opportunities for master's-level and pre-doctoral psychology students in evidence-based assessment and treatment of adolescent EDs; 2) to provide the healthcare workforce, including licensed health professionals such as primary care physicians and behavioral health interventionists, with knowledge and competence to recognize early symptoms of and intervention strategies for EDs; and 3) to test the efficacy of delivering two evidence-based treatments for adolescent eating disorders, Family Based Treatment (FBT) and Enhanced Cognitive Behavioral Therapy (CBT-E), in the home-based setting.

Study Overview

• Status: Unknown
• Conditions: Eating Disorders in Adolescence; Anorexia Nervosa/Bulimia; Anorexia Nervosa Restricting Type
• Intervention / Treatment: Behavioral: Family Based Treatment; Behavioral: Enhanced Cognitive Behavioral Therapy

Detailed Description

The complete project will incorporate three phases. Phase I is designed to gather information from existing licensed health professionals in the community who serve Medicaid populations on their knowledge needs and priorities related to screening and intervening with patients with eating disorders. Phase I will comprise eating disorder psycho-education, implementation of workshops, and supervision among primary care professionals and mental health workers. Responses will inform the content of in-services and program development (e.g., monthly consultation services, ongoing multi-family support groups) provided in Phase II.

During Phase II, families containing a child with a restrictive-type eating disorder will be recruited to receive treatment from the clinicians assessed and trained during Phase I. Families will be assigned to receive either Family Based Treatment (FBT) or Enhanced Cognitive Behavioral Therapy (CBT-E) to treat their adolescent's eating disorder. Treatment will occur over 10-16 weeks, depending on the family's needs and availability. Families will be assessed at pre-treatment, post-treatment, and 1-year follow-up.

Phase III will consist of follow-up with the families and clinicians, and further development of training/education approaches for the Rhode Island healthcare workforce.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Erin R. Stalvey; Phone Number: (401) 793-8962; Email: estalvey@lifespan.org
• Study Contact Backup: Name: Eva-Molly Dunbar; Email: epetittodunbar@my.uri.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • The Weight Control & Diabetes Research Center
      • Contact: Eva-Molly Dunbar; Email: epetittodunbar@my.uri.edu
      • Contact: Erin R. Stalvey; Phone Number: 401-793-8962; Email: estalvey@lifespan.org
      • Principal Investigator: Andrea B. Goldschmidt, Ph.D.
      • Principal Investigator: Christina Tortolani, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria include:

• meets criteria for AN, atypical AN, or BN according to DSM-5 diagnostic criteria
• is currently living at home
• is medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute)
• if on a psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication (8 weeks) for a co-morbid condition
• speaks English
• be available for long-term follow-up.

Exclusion criteria include:

• associated physical illness that necessitates hospitalization
• psychotic illness/other mental illness requiring hospitalization
• current dependence on drugs or alcohol
• physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
• concurrent involvement in other psychological treatment for an eating disorder
• developmental delay that would preclude participation in the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FBT; 10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.	Behavioral: Family Based Treatment; 10 families will be randomized to receive 10 - 16 weeks of Family Based Treatment (FBT), the "gold standard" in eating disorder treatment for adolescents. FBT is a highly structured behavioral intervention in which caregivers are charged with the primary task of re-feeding their child and normalizing his or her eating behaviors and weight status.; Other Names: FBT
EXPERIMENTAL: CBT-E; 10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.	Behavioral: Enhanced Cognitive Behavioral Therapy; 10 families will be randomized to receive 10 - 16 weeks of Enhanced Cognitive Behavioral Therapy (CBT-E), a clinically validated treatment for adolescent eating disorders. CBT-E is a short-term, individual treatment focused on normalizing eating behaviors and modifying underlying cognitions that contribute to the maintenance of eating disorder behaviors (e.g., over-importance of shape and weight in one's self-evaluation).; Other Names: CBT-E

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI percentile		post treatment (week 17)
BMI percentile		1 year follow up
Eating disorder symptomology, as assessed by the EDE-Q.	Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Averages of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology.	post treatment (week 17)
Eating disorder symptomology, as assessed by the ED-15.	Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology.	post treatment (week 17)
Eating disorder symptomology, as assessed by EDE-Q	Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology.	1 year follow-up
Eating disorder symptomology, as assessed by ED-15.	Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology.	1 year follow-up
Perceived efficacy of treatment, as assessed by the TSPE	One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy.	post treatment (week 17)
Perceived efficacy of treatment, as assessed by the CSQ	The Client Satisfaction Questionnaire (CSQ) is an 8-item measure that assesses how successful the patient perceived treatment to be. Average scores range from 1 - 4, with higher scores indicating higher satisfaction and perceived efficacy.	post treatment (week 17)
Perceived efficacy of treatment, as assessed by the CSQ	The Client Satisfaction Questionnaire (CSQ) is an 8-item measure that assesses how successful the patient perceived treatment to be. Average scores range from 1 - 4, with higher scores indicating higher satisfaction and perceived efficacy.	1 year follow-up
Perceived efficacy of treatment, as assessed by the TSPE.	One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy.	1 year follow-up
Perceived feasibility of treatment, as assessed by the TSPE.	One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how feasible the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher feasibility.	post treatment (week 17)
Perceived feasibility of treatment, as assessed by the CSQ.	Two items from the 8-item Client Satisfaction Questionnaire (CSQ) will assess how suitable/feasible treatment was based on the patient's needs, family dynamics, schedule constraints, etc. Average scores range from 1 - 4, with higher scores indicating higher feasibility.	post treatment (week 17)

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Investigators: Principal Investigator: Andrea B. Goldschmidt, Ph.D., Weight Control & Diabetes Research Center; Principal Investigator: Christina Tortolani, Ph.D., Rhode Island College

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (ACTUAL): February 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Adolescence; Bulimia Nervosa; Family Based Treatment; Anorexia Nervosa; Eating Disorders; Enhanced Cognitive Behavioral Therapy; Clinical Training; Community Outreach
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Hyperphagia; Anorexia; Anorexia Nervosa; Disease; Bulimia; Feeding and Eating Disorders
• Other Study ID Numbers: 1319865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No